Nearly every human society has figured out how to get high. This behavior isn’t limited to Homo Sapiens—a number of animals also do recreational drugs. So why do we and some of our finned and hoofed brethren seek to escape normal consciousness? Well, as an active participant in normal consciousness, I don’t find the mystery too great: normal consciousness often sucks. Our brains are powerful problem-solving machines that evolved to protect and pass along our genes. In many situations, achieving that goal is unrelated to being happy.
“The mental healthcare system is so badly broken, it doesn’t even qualify as a system.” This indictment, coming from Tom Insel, the former director of the National Institute of Mental Health, is not due to lack of effort. The U.S. spends over $200 billion on mental healthcare treatment each year, double what we spent in 2005. American suicides are at a fifty year high and increasing at an increasing rate. Over 70,000 Americans died of drug overdoses in 2017, twice as many as did in 2007.
Our best responses to depression, addiction, and PTSD haven’t changed much. SSRI’s, introduced in the 1980s, work only with some forms of depression, have not improved, and carry side-effects that their users hate. Only 8 to 12 percent of Alcoholics Anonymous (AA) members get sober after the first year, and the organization has resisted the introduction of more effective drug-based treatments. Talk-based therapy is expensive, time-consuming, and often ineffective.
Rather than throw up their hands in the face of maladies that are affecting tens of millions of Americans and hundreds of millions more worldwide, researchers are turning back to a class of compounds that have were exiled from the medical establishment over 40 years ago.
Classical psychedelics were administered to over 10,000 people in research settings in the 1950s and ’60s. Acting primarily on the 5HT2A subtype of serotonin receptors and sharing a similar chemical structure, classical psychedelics are generally thought of as psilocybin (the active ingredient in magic mushrooms), LSD, mescaline, and DMT. MDMA (i.e. Molly or Ecstasy) shares some features, but is neurotoxic at high doses and can lead to dependencies not seen in the classical psychedelics. Classical psychedelics share more than just structure and method of action, they are anti-addictive (they help users break addictions and don’t create dependencies themselves), non-toxic, and generally affect the mind far more than they affect the body. (Someone tripping on a high dose of LSD will exhibit normal vital signs, and the only external evidence of the experience is pupil dilation). (...)
Recent psychedelic research has demonstrated the ability of psychedelics to beat our current best treatments for depression, addiction, PTSD, smoking, alcoholism, and existential anxiety. A lot of these studies are conducted by highly-motivated researchers on small samples and may not generalize. But the promise of psychedelics across such a wide range of ailments may indicate that mental illnesses aren’t as varied as the Diagnostic and Statistical Manual of Mental Disorders would have us believe. The ability of psychedelics to help people with treatment-resistant mental illness (those that persist after two or more forms of treatment have been attempted) may foreshadow even better results in populations with less severe conditions. David Nutt, Britain’s former director of the Advisory Council on the Misuse of Drugs, told me over email that these results are “almost certain” to generalize. (...)
After showing so much promise as a therapeutic tool and revealing deep truths about the mind (the discovery of LSD’s similarity to serotonin arguably kicked off modern neuroscience), LSD, psilocybin, and mescaline are Schedule I drugs: they have high potential for abuse and no accepted medical uses. Research significantly dropped off in 1966 and froze in 1976.
What happened?
Nixon declared the start of the “War on Drugs” in 1971, but the first shots were fired far earlier. The United States has a long history of criminalizing drugs associated with social undesirables, detailed in Johann Hari’s book Chasing the Scream. Premonitions of the war to come can be found in late 19th century. Fears of Chinese immigrants using opium to seduce white women contributed to the Chinese Exclusion Act in 1882. A 1914 New York Times headline informed their readers that “Negro Cocaine ‘Fiends’ Are a New Southern Menace.” This climate led to the passage of the Harrison Act the same year, which effectively criminalized cocaine and heroin.
Harry Anslinger, the fanatical and viciously racist founder of the Federal Bureau of Narcotics, is the founding father of the drug war. In the 1920s, Anslinger prosecuted 35,000 doctors for prescribing controlled drugs to addicts, overriding a Supreme Court decision (this would not be the first time drug enforcers ignored judicial opinion) and ceding control of addictive drugs to the black market. After successfully pushing for marijuana criminalization in 1937, Anslinger took his show on the road. Invoking fears of Chinese “Communist heroin”, he threatened to cut other countries off from American foreign aid and markets if they didn’t adopt drug laws similar to America’s. In the words of a retired DEA agent, “He was truly the founder of international drug enforcement.”
There is a tendency to see the backlash to psychedelics as an avoidable tragedy brought on by the “antics” of Timothy Leary and other evangelizers. While psychedelics may have seemed poised to become a part of the mainstream, the infrastructure to criminalize substances in the face of all evidence was built long before Leary emerged on the scene.
The history of the psychedelic 1960s is well-documented in Martin Lee and Bruce Shlain’s Acid Dreams: the Complete Social History of LSD. The media narrative went something like this: an extremely promising drug (LSD) was being used responsibly and to great effect by pioneering therapists and intellectuals. Along come reckless scientists like Timothy Leary and counter-culture populists like Ken Kesey, who heave psychedelics over the wall separating the educated classes from the great unwashed. In response to the social and public health crisis that resulted from millions of people turning on, tuning in, and dropping out the government steps in, first when the FDA regulated acid as an experimental drug in 1962, then when California banned it in 1966, with the final nail coming with the 1970 Controlled Substances Act, which inaugurated the modern war on drugs. (...)
James Fadiman told me that he thinks Compass is attempting to control part of the psilocybin market, but they’re also trying to move things forward as fast as possible and get governments and insurance companies to cover the cost, which compares favorably with decades of SSRI treatment.
Rick and others in the psychedelic establishment (yes, there is such a thing) claim not to be worried about Compass. One reason Rick isn’t particularly concerned is that Compass has a competitor from Usona, a nonprofit that is also trying to do psilocybin therapy. The idea is, if Compass charges too much, Usona can compete. But Usona has struggled to get its own source of Good Manufacturing Practices (GMP) psilocybin, a requirement for FDA approval. Compass is trying to patent its method of manufacturing psilocybin, which could ensure that it has a significant cost advantage over competitors, who would need to develop their own means of making GMP psilocybin. The reality is that nonprofits don’t have many of the advantages of a venture-funded for-profit. To go through the FDA, an enormous amount of startup capital is required, erecting a large barrier to entry that nonprofits will struggle to surmount. MAPS needed to raise $27 million to take MDMA through FDA approval. (...)
The pushback to Compass Pathways is sometimes framed as the overreaction to the mainstreaming of a previously fringe movement: Compass is just doing business as usual in a space where business is unusual. Rick sees the entrance of for-profit players like Compass as a healthy sign for psychedelics: people think they’re a good investment. The allure of tax revenues and big returns helped legalize marijuana. But legal marijuana became quickly became commercialized marijuana, leading to some of the problems we face with alcohol and tobacco: powerful industry lobbies resisting regulation and misleading labeling and advertising. As one marijuana entrepreneur said at an alcohol industry conference, “I fundamentally believe that it is Big Alcohol and Big Tobacco that will be my future employer.”
Given the way for-profit companies have handled drugs, skepticism is warranted. Researchers, advocates and practitioners who have spent decades working to make psychedelics safely available to more people are understandably terrified of a company focused on the bottom line moving too fast and setting the movement back. Compass is running studies with 400 people in eight countries based off of research done with a very small group of people. Psilocybin poses psychological risks that MDMA doesn’t, and MAPS therapists undergo substantially more training.
At the same time, 300 million people around world experience depression, and Compass has moved faster than Usona. It may be the case that MAPS training and protocols are overkill, and that the Compass approach is safe and far more scalable and cost-effective. As Compass embarks on larger scale research, Katherine MacLean sincerely hopes for their success. For the sake of all the people who could be helped by psilocybin treatment, I do too.
The final approach may be the best we can hope for in the near term. An excellent series from Psymposia lays out the future of MDMA. MAPS has established a public benefit corporation that has the exclusive rights to conduct MDMA therapy for five years, should the treatment get approved by the FDA. The public benefit corporation is separate from MAPS, but MAPS is the sole shareholder. Any profits from the corporation go back into MAPS research, which is publicly available. From what I can tell, Rick is genuinely committed to making psychedelic therapy available to as many people as possible (MAPS has hired a patent lawyer to develop anti-patent strategies to ensure that nobody can patent the use of MDMA). The way to get there seems to be by jumping through expensive and onerous hoops to prove the safety and efficacy of psychedelics to the FDA.
There are still risks and drawbacks to the MAPS approach. If the FDA Phase III trials are successful, only MAPS’ GMP MDMA will be re-scheduled by the DEA. And legal risks for recreational users could persist as re-scheduling won’t necessarily change criminal penalties associated with the drug. For the five years that MAPS has a monopoly on MDMA therapy, only therapists trained by MAPS will be able to conduct therapy or trainings of their own, creating a potential bottleneck in the number of people who can legally provide MDMA-assisted therapy. The associated costs are considerable. Training for this therapy can cost more than $9,000. The current protocols for MDMA treatment involve many therapy sessions with a two-person co-therapy team that can cost up to $15,000 altogether. There are strict requirements on prospective MDMA-assisted therapy clinic: two MAPS-trained therapists, a prescribing physician who can obtain a DEA Schedule I license, access to a lab for bloodwork, and a cardiologist. Clinics must be established businesses with the facilities to meet therapeutic and security standards.
[ed. Looks like it's heading the same way of ketamine treatments. Expensive regimens only the rich can afford. But... baby steps. See also: Women Who Microdose Mushrooms, and It Happened to Her (because I just finished Cat Marnell's How to Murder Your Life.)]
“The mental healthcare system is so badly broken, it doesn’t even qualify as a system.” This indictment, coming from Tom Insel, the former director of the National Institute of Mental Health, is not due to lack of effort. The U.S. spends over $200 billion on mental healthcare treatment each year, double what we spent in 2005. American suicides are at a fifty year high and increasing at an increasing rate. Over 70,000 Americans died of drug overdoses in 2017, twice as many as did in 2007.
Our best responses to depression, addiction, and PTSD haven’t changed much. SSRI’s, introduced in the 1980s, work only with some forms of depression, have not improved, and carry side-effects that their users hate. Only 8 to 12 percent of Alcoholics Anonymous (AA) members get sober after the first year, and the organization has resisted the introduction of more effective drug-based treatments. Talk-based therapy is expensive, time-consuming, and often ineffective.Rather than throw up their hands in the face of maladies that are affecting tens of millions of Americans and hundreds of millions more worldwide, researchers are turning back to a class of compounds that have were exiled from the medical establishment over 40 years ago.
Classical psychedelics were administered to over 10,000 people in research settings in the 1950s and ’60s. Acting primarily on the 5HT2A subtype of serotonin receptors and sharing a similar chemical structure, classical psychedelics are generally thought of as psilocybin (the active ingredient in magic mushrooms), LSD, mescaline, and DMT. MDMA (i.e. Molly or Ecstasy) shares some features, but is neurotoxic at high doses and can lead to dependencies not seen in the classical psychedelics. Classical psychedelics share more than just structure and method of action, they are anti-addictive (they help users break addictions and don’t create dependencies themselves), non-toxic, and generally affect the mind far more than they affect the body. (Someone tripping on a high dose of LSD will exhibit normal vital signs, and the only external evidence of the experience is pupil dilation). (...)
Recent psychedelic research has demonstrated the ability of psychedelics to beat our current best treatments for depression, addiction, PTSD, smoking, alcoholism, and existential anxiety. A lot of these studies are conducted by highly-motivated researchers on small samples and may not generalize. But the promise of psychedelics across such a wide range of ailments may indicate that mental illnesses aren’t as varied as the Diagnostic and Statistical Manual of Mental Disorders would have us believe. The ability of psychedelics to help people with treatment-resistant mental illness (those that persist after two or more forms of treatment have been attempted) may foreshadow even better results in populations with less severe conditions. David Nutt, Britain’s former director of the Advisory Council on the Misuse of Drugs, told me over email that these results are “almost certain” to generalize. (...)
After showing so much promise as a therapeutic tool and revealing deep truths about the mind (the discovery of LSD’s similarity to serotonin arguably kicked off modern neuroscience), LSD, psilocybin, and mescaline are Schedule I drugs: they have high potential for abuse and no accepted medical uses. Research significantly dropped off in 1966 and froze in 1976.
What happened?
Nixon declared the start of the “War on Drugs” in 1971, but the first shots were fired far earlier. The United States has a long history of criminalizing drugs associated with social undesirables, detailed in Johann Hari’s book Chasing the Scream. Premonitions of the war to come can be found in late 19th century. Fears of Chinese immigrants using opium to seduce white women contributed to the Chinese Exclusion Act in 1882. A 1914 New York Times headline informed their readers that “Negro Cocaine ‘Fiends’ Are a New Southern Menace.” This climate led to the passage of the Harrison Act the same year, which effectively criminalized cocaine and heroin.
Harry Anslinger, the fanatical and viciously racist founder of the Federal Bureau of Narcotics, is the founding father of the drug war. In the 1920s, Anslinger prosecuted 35,000 doctors for prescribing controlled drugs to addicts, overriding a Supreme Court decision (this would not be the first time drug enforcers ignored judicial opinion) and ceding control of addictive drugs to the black market. After successfully pushing for marijuana criminalization in 1937, Anslinger took his show on the road. Invoking fears of Chinese “Communist heroin”, he threatened to cut other countries off from American foreign aid and markets if they didn’t adopt drug laws similar to America’s. In the words of a retired DEA agent, “He was truly the founder of international drug enforcement.”
There is a tendency to see the backlash to psychedelics as an avoidable tragedy brought on by the “antics” of Timothy Leary and other evangelizers. While psychedelics may have seemed poised to become a part of the mainstream, the infrastructure to criminalize substances in the face of all evidence was built long before Leary emerged on the scene.
The history of the psychedelic 1960s is well-documented in Martin Lee and Bruce Shlain’s Acid Dreams: the Complete Social History of LSD. The media narrative went something like this: an extremely promising drug (LSD) was being used responsibly and to great effect by pioneering therapists and intellectuals. Along come reckless scientists like Timothy Leary and counter-culture populists like Ken Kesey, who heave psychedelics over the wall separating the educated classes from the great unwashed. In response to the social and public health crisis that resulted from millions of people turning on, tuning in, and dropping out the government steps in, first when the FDA regulated acid as an experimental drug in 1962, then when California banned it in 1966, with the final nail coming with the 1970 Controlled Substances Act, which inaugurated the modern war on drugs. (...)
Compass Pathways is the controversial startup that recently secured FDA approval for psilocybin as a breakthrough treatment. Originally a nonprofit, Compass has been criticized for capitalizing on the work of academic and nonprofit researchers to develop their business. A Quartz investigation describes how Compass courted researchers as a nonprofit, then iced them out and transferred its intellectual property to the company’s founders before transitioning to for-profit status. When a charity is dissolved, it is required to distribute its assets to other charities, a requirement Compass appears to have violated. The conditions Compass puts on research it sponsors are “restrictive contracts even by pharmaceutical industry standards, according to John Abramson, lecturer in health care policy at Harvard Medical School, and have the potential to distort the publicly available body of scientific knowledge.” David Nutt told me via email that this practice is “necessary under current commercial funding routes to [a] successful clinical trial outcome.” (The idea is that competitors could piggy-back off of Compass’s research and undercut the resulting products). The company only requires a weekend of training for its therapists and does not require them to have personal experience with psilocybin. (...)
James Fadiman told me that he thinks Compass is attempting to control part of the psilocybin market, but they’re also trying to move things forward as fast as possible and get governments and insurance companies to cover the cost, which compares favorably with decades of SSRI treatment.
Rick and others in the psychedelic establishment (yes, there is such a thing) claim not to be worried about Compass. One reason Rick isn’t particularly concerned is that Compass has a competitor from Usona, a nonprofit that is also trying to do psilocybin therapy. The idea is, if Compass charges too much, Usona can compete. But Usona has struggled to get its own source of Good Manufacturing Practices (GMP) psilocybin, a requirement for FDA approval. Compass is trying to patent its method of manufacturing psilocybin, which could ensure that it has a significant cost advantage over competitors, who would need to develop their own means of making GMP psilocybin. The reality is that nonprofits don’t have many of the advantages of a venture-funded for-profit. To go through the FDA, an enormous amount of startup capital is required, erecting a large barrier to entry that nonprofits will struggle to surmount. MAPS needed to raise $27 million to take MDMA through FDA approval. (...)
The pushback to Compass Pathways is sometimes framed as the overreaction to the mainstreaming of a previously fringe movement: Compass is just doing business as usual in a space where business is unusual. Rick sees the entrance of for-profit players like Compass as a healthy sign for psychedelics: people think they’re a good investment. The allure of tax revenues and big returns helped legalize marijuana. But legal marijuana became quickly became commercialized marijuana, leading to some of the problems we face with alcohol and tobacco: powerful industry lobbies resisting regulation and misleading labeling and advertising. As one marijuana entrepreneur said at an alcohol industry conference, “I fundamentally believe that it is Big Alcohol and Big Tobacco that will be my future employer.”
Given the way for-profit companies have handled drugs, skepticism is warranted. Researchers, advocates and practitioners who have spent decades working to make psychedelics safely available to more people are understandably terrified of a company focused on the bottom line moving too fast and setting the movement back. Compass is running studies with 400 people in eight countries based off of research done with a very small group of people. Psilocybin poses psychological risks that MDMA doesn’t, and MAPS therapists undergo substantially more training.
At the same time, 300 million people around world experience depression, and Compass has moved faster than Usona. It may be the case that MAPS training and protocols are overkill, and that the Compass approach is safe and far more scalable and cost-effective. As Compass embarks on larger scale research, Katherine MacLean sincerely hopes for their success. For the sake of all the people who could be helped by psilocybin treatment, I do too.
The final approach may be the best we can hope for in the near term. An excellent series from Psymposia lays out the future of MDMA. MAPS has established a public benefit corporation that has the exclusive rights to conduct MDMA therapy for five years, should the treatment get approved by the FDA. The public benefit corporation is separate from MAPS, but MAPS is the sole shareholder. Any profits from the corporation go back into MAPS research, which is publicly available. From what I can tell, Rick is genuinely committed to making psychedelic therapy available to as many people as possible (MAPS has hired a patent lawyer to develop anti-patent strategies to ensure that nobody can patent the use of MDMA). The way to get there seems to be by jumping through expensive and onerous hoops to prove the safety and efficacy of psychedelics to the FDA.
There are still risks and drawbacks to the MAPS approach. If the FDA Phase III trials are successful, only MAPS’ GMP MDMA will be re-scheduled by the DEA. And legal risks for recreational users could persist as re-scheduling won’t necessarily change criminal penalties associated with the drug. For the five years that MAPS has a monopoly on MDMA therapy, only therapists trained by MAPS will be able to conduct therapy or trainings of their own, creating a potential bottleneck in the number of people who can legally provide MDMA-assisted therapy. The associated costs are considerable. Training for this therapy can cost more than $9,000. The current protocols for MDMA treatment involve many therapy sessions with a two-person co-therapy team that can cost up to $15,000 altogether. There are strict requirements on prospective MDMA-assisted therapy clinic: two MAPS-trained therapists, a prescribing physician who can obtain a DEA Schedule I license, access to a lab for bloodwork, and a cardiologist. Clinics must be established businesses with the facilities to meet therapeutic and security standards.
by Garrison Lovely, Current Affairs | Read more:
Image: Nick Sirotich[ed. Looks like it's heading the same way of ketamine treatments. Expensive regimens only the rich can afford. But... baby steps. See also: Women Who Microdose Mushrooms, and It Happened to Her (because I just finished Cat Marnell's How to Murder Your Life.)]
